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Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. These studies should result in clinically validated biomarkers and clinical outcome assessment measures appropriate for use in upcoming clinical trials. Through the support of trial readiness studies, NINDS and NCATS expect to enhance the quality and increase the likelihood of success of clinical trials in these rare diseases.
Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This purpose of this FOA is to identify risk factors for dementia progression in PDD. Applicants must have access to well-characterized populations of PDD patients that have been followed longitudinally that they can continue to follow with clinical assessments and biospecimen collection until autopsy. Research should propose to identify clinical, pathological and/or biospecimen factors that predict which patients will develop cognitive impairment and/or dementia.
Functional Target Validation for Alzheimer's Disease-Related Dementias (ADRDs) (UG3/UH3 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This FOA invites applications that propose the comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer's Disease-Related Dementias (ADRDs). This FOA seeks to promote critical target validation approaches to help de-risk subsequent translational research and accelerate the advancement of novel therapies for ADRD. Target(s) or molecular pathway(s) to be considered for validation must have been already identified using tissue expression or genetic data generated in human samples. In its initial phase, this FOA provided support for up to two years (UG3 stage) for the development of customized technologies, models, and protocols to modulate the expression or activity of target candidate(s) in cells or tissues and monitor their functional biological consequences in in vitro or in vivo disease models. Upon demonstration of technical feasibilities, a second phase (UH3 stage) will carefully and reproducibly measure and cross-validate the impact of the target modulation in different modalities across collaborating laboratories using the NIH rigor and reproducibility guidelines. Applicants responding to this FOA must address objectives for both the UG3 and UH3 phases and are expected to have a substantial collaborative effort between independents laboratories. This FOA is not specific for any one or group within the ADRD spectrum of disorders. Disorders covered in these applications are frontotemporal degeneration (FTD), Lewy body dementias (LBD) (including dementia with Lewy bodies (DLB)), Parkinson disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), mixed dementias including the associated diagnostic challenges of multiples etiology dementias (MED).
NINDS Institutional Research Training Program (T32)
Funding Opportunity Purpose
The purpose of this FOA is to provide support for institutional research training programs in areas relevant to the NINDS mission. These institutional research training programs should produce well-trained neuroscientists who leave the program with the research skills and scientific knowledge to make a significant contribution to neuroscience research. Programs should be designed to enhance the breadth and depth of training in NINDS mission areas by incorporating didactic, research and career development components in the context of a defined scientific theme. Programs may support basic, clinical and/or translational research. Critical components of programs supported by this FOA include mechanisms to ensure a thorough understanding of experimental design, strong statistics and analytical skills, and skills for communicating science, both orally and in writing, to a wide variety of audiences. Regardless of theme, programs should provide opportunities and activities that will foster the development of quantitative literacy and the application of quantitative approaches to the trainees' research. NINDS institutional training programs are intended to be 1-2 years in duration and support training of one or more of the following groups: dissertation stage predoctoral students in their 3rd and/or 4th year of graduate school, postdoctoral fellows and fellowship-stage clinicians. (NINDS does not support first or second year graduate students under this PAR).
Clinical and Biological Measures of TBI-related dementia including Chronic Traumatic Encephalopathy (CTE) (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This FOA invites investigation of biological and clinical measures of TBI-related progressive neurodegeneration and neurocognitive decline associated with increased risk for dementia and /or traumatic encephalopathy syndrome (TES) (clinicopathologic diagnostic counterpart to the neuropathological diagnosis of Chronic Traumatic Encephalopathy (CTE)). The overall goal is to advance knowledge of the underlying pathophysiology and clinical characterization of the chronic effects of TBI that distinguish static-chronic TBI cognitive impairment from those that lead to progressive neurodegeneration associated with TES and dementia. Investigations should be conducted in existing, well-characterized populations of patients with a history of TBI, enriched for increased risk of cognitive impairment or dementia, that have been and can continue to be followed longitudinally. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in this area.
Neuropathological Assessment of TBI-related Neurodegeneration and Neurocognitive decline - Center Without Walls (NATBI CWOW) (U54 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This FOA invites applications for a multisite study to comprehensively characterize the neuropathological features associated with neurodegeneration and neurocognitive decline in persons with a history of traumatic brain injury (TBI). Investigations should elucidate the contribution of key individual (sex, age at time of injury, time since injury, etc) and injury characteristics (injury severity and frequency) to describe associations between neuropathological burden and antemortem clinicopathologic symptoms, and outline the prevalence of TBI-related parkinsonism, TBI-related Alzheimers, and CTE in the participating brain banks. To further advance research in the area, broad sharing of clinical and neuropathological data will be a critical feature of this FOA including the development of a digital resource for distribution and sharing of assessed neuropathological tissue.
Summer Research Education Experience Program (R25 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. The proposed program needs to fit within the mission of the participating IC that the application is being submitted to and should not have a general STEM focus (see below and Table of IC-Specific Information and Points of Contact).
Post-Stroke Vascular Contributions to Cognitive Impairment and Dementia (VCID) in the United States Including in Health Disparities Populations (U19 Clinical Trial not Allowed)
Funding Opportunity Purpose
The National Institute of Neurological Disorders and Stroke (NINDS) and National Institute on Aging (NIA) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for a large prospective clinical research study to determine the specific subsets of stroke events that predict cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations, and what additional clinical factors and comorbidities along the AD/ADRD spectrum may causally synergize with stroke to result in (or prevent) cognitive impairment and dementia outcomes. The goals of this initiative are to determine the association between specific subsets of stroke events and subsequent cognitive impairment and dementia in post-stroke populations in the United States, including in health disparities populations; to identify additional clinical factors and comorbidities that may affect these associations; and to contribute to development and validation of clinical-trial ready diagnostic and progression biomarkers for post-stroke dementia. It is expected that the study design will also allow for determination of interrelationships (cross-sectional and longitudinal) among the stroke event, overall cerebrovascular and cardiovascular disease and risk factors (including sex, racial, and ethnic differences), dementia-relevant genetic variants (including ApoE) and mutations (e.g. in Notch 3) previously associated with Alzheimer's disease (e.g. APP, PS1, PS2, PICALM, CLU, TREM2), cognitive trajectories including decline and resistance to decline, as well as amyloid and tau biomarkers of Alzheimers pathology during life.
Biological Measures for Prognosing and Monitoring of Persistent Concussive Symptoms in Early and Middle Adolescents: Center Without Walls (PCS-EMA CWOW) (U54 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) is aimed at discovering, determining the selectivity and sensitivity, and externally validating biological measures to be used for assessing, prognosing and monitoring recovery of youth who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion. Resultant biological measures should be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in children ages 9 - 14.
Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (https://www.ninds.nih.gov/). Studies proposed should provide a cost-effective means of collecting data with a meaningful bearing on current clinical practice. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a observational study phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase for observational studies will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of data collection, storage, and planned analyses. Operational planning activities include, at a minimum, development of recruitment and retention strategies, case report forms, data management system and other tools for data and quality management. The UH3 phase of the award will support the conduct of investigator-initiated observational study.